This study is for a population of patients with few or no alternative options that was conducted to determine the response rate to clofarabine. Additionally the study will provide information on the safety profile, impact of overall survival, and impact on remission duration with clofarabine. It is a single arm study and has no comparator.

Overall response rate after 1 course or more [ Time Frame: minimum of 1 course and maximum of 12 courses ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall response rate after 2 courses or more [ Time Frame: minimum of 2 courses and maximum of 12 courses ] [ Designated as safety issue: No ]

Rate of response (complete, complete with incomplete blood count recovery, partial) after 1 course or more [ Time Frame: minimum of 1 course and maximum of 12 courses ] [ Designated as safety issue: No ]

Time-to-event parameters including duration of remission and overall survival [ Time Frame: Until death of patient or until end of study treatment for last enrolled patient ] [ Designated as safety issue: No ]

Safety and tolerability [ Time Frame: Until death of patient or until end of study treatment for last enrolled patient ] [ Designated as safety issue: Yes ]

Number of patients received bone marrow or peripheral blood stem cell transplantation and the time to transplant following commencement of Clofarabine [ Time Frame: Until death of patient or until end of study treatment for last enrolled patient ] [ Designated as safety issue: No ]

Determine pharmacokinetic profile and intracellular triphosphate and levels of clofarabine [ Time Frame: every day during the first course of treatment ] [ Designated as safety issue: No ]

Document the metabolic pathways that may predict Clofarabine sensitivity or resistance [ Time Frame: day 1, day 5, day 6 and day 7 of the first course ] [ Designated as safety issue: No ]

Eligible patients must have: Primary refractory disease; OR relapsed or refractory disease after a minimum of 2 prior blocks of treatment.

Must not be eligible for therapy of higher curative potential.

Have a Karnofsky Performance Status of ≥ 50 or Lansky Performance Scale of ≥ 30.

Provide a signed, written informed consent from parent or guardian or young adult patients.

Be able to comply with study procedures and follow-up examinations.

Have adequate cardiac function without treatment.

Have adequate organ function as indicated by the laboratory values for serum creatinine, serum bilirubin, AST and ALT, obtained within 7 days prior to registration.

Exclusion Criteria:

Received previous treatment with clofarabine.

Patients with isolated extramedullary disease.

Have received prior BMT or PBSCT within the last 6 months.

Have received prior BMT or PBSCT more than 6 months ago, but now has compromised organ function.

Have an active, uncontrolled systemic infection.

Are pregnant or lactating. Male and female patients who are fertile must agree to use an effective means of birth control to avoid pregnancy.

Have a psychiatric disorder that would interfere with consent, study participation, or follow-up.

Have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity oa all previous therapy prior to enrollment.

Have any other severe concurrent disease.

Have recent history of significant renal, hepatic or pulmonary dysfunction, or cardiac dysfunction or on treatment to support cardiac function.

Have CNS disease.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930098